. How can large manufacturers handle the various verifications the manufacturer, importer and distributor need to perform and avoid duplication? (related to MEDTECH Europe document)
. IS "placing on the market" and "making available" triggered by PHYSICAL ownership AS WELL as legal ownership?
. Are 3rd Party logistics providers (e.g. Healthlink, Rhenus, UPS) who are Fulfillment Service Providers also distributors?
. Challenges with the point of "placing on the market" for capital equipment (and devices which must be installed) - who then is the importer? Who is the distributor?
. Should Economic Operators be managed through the Supplier Management process within the QMS (ISO 13485:2016 clause 7.4)?